Neurosteer, a developer of wearable brain activity interpretation platform, has secured the US Food and Drug Administration (FDA) approval for its single-channel EEG brain monitoring platform.
The platform leverages an adhesive electrode strip connected to a pocket-sized sensor that wirelessly transmits EEG data to the cloud to advance the legacy EEG technology.
The advanced solution offers the traditional EEG frequency bands, while also including a visual representation of various novel brain metrics.
Built on Neurosteer’s advanced signal processing technology, the brain metrics will help the trained medical staff in making neurological diagnoses.
The adhesive strips are affixed to the forehead using dry gel, which eliminates interference from the hair, and supports unattended operation for up to 12 hours.
In addition, the system enables a non-invasive assessment with auditory prompts that support the early detection of brain deterioration, said the company.
Neurosteer founder and CEO Nathan Intrator said: “We are extremely pleased that the FDA has cleared our portable and affordable EEG system, and moreover, recognised the potential clinical value of our brain metrics visual representations.
“This is an important step in achieving our goal of making brain monitoring and assessment widely available to all populations.”
With the FDA approval, Neurosteer is now allowed to use its unobtrusive multi-purpose system in a wide range of clinical settings.
The system can be used in the ICU setting to enable continuous brain monitoring to support critical interventions.
It can be used in a doctor’s office to support the early detection of pre-symptomatic cognitive decline, including Alzheimer’s, Parkinson’s disease, and dementia
Furthermore, the system can be used in pharma drug trials, and assist in the rapid and cost-effective mass screening of subjects suffering from neurodegenerative disorders.
Western Galilee Hospital surgeon Amitai Bickel said: “After working with the Neurosteer EEG system for several years, I’ve realised what an advantage it is to have a compact, easy-to-apply EEG brain monitor that can be used for real-time continuous monitoring.
“Neurosteer’s innovative platform has the potential to revolutionise the standard of care in managing brain health.”
